Welcome to our dedicated page for Ocugen news (Ticker: OCGN), a resource for investors and traders seeking the latest updates and insights on Ocugen stock.
Ocugen Inc. (OCGN) is a clinical-stage biopharmaceutical company pioneering gene therapies for retinal diseases and innovative vaccine platforms. This dedicated news hub provides investors and researchers with timely updates on Ocugen’s scientific advancements, regulatory milestones, and strategic initiatives.
Access verified press releases and curated financial news covering clinical trial developments, partnership announcements, and corporate updates. Our repository includes updates on modifier gene therapy programs for conditions like retinitis pigmentosa, inhaled vaccine research, and ocular disorder treatments undergoing regulatory review.
Key content categories include progress reports on Phase I-III trials, FDA designations, intellectual property updates, and financial performance summaries. Bookmark this page for streamlined tracking of OCGN’s advancements in gene editing technologies and mucosal vaccine development.
Ocugen announced a clinical hold from the FDA on its Investigational New Drug application for the COVID-19 vaccine candidate COVAXIN™ (BBV152). The FDA will specify deficiencies leading to the hold, and Ocugen plans to address these promptly. COVAXIN™, developed by Bharat Biotech, has shown 77.8% overall efficacy in Phase 3 trials with 25,800 participants. Despite over 100 million doses administered globally, the FDA's hold may impact future emergency use authorization requests.
Ocugen (NASDAQ: OCGN) announced on November 18, 2021, that its Board's Compensation Committee granted stock options for 93,000 shares and restricted stock units (RSUs) for 15,600 shares to six employees. The stock options have a ten-year term and an exercise price of $8.13 per share, based on the stock's closing price on the grant date. Vesting occurs over three years, contingent on continued employment. This grant is in accordance with Nasdaq rules and is outside Ocugen's 2019 Equity Incentive Plan, reflecting the company's commitment to employee retention and motivation.
Ocugen filed an Emergency Use Authorization application for its COVID-19 vaccine candidate, COVAXIN™ (BBV152), targeting children aged 2-18. The company also submitted Investigational New Drug applications for both COVAXIN™ and its gene therapy candidate OCU400. The collaboration with CanSinoBIO has expanded to include OCU410 for manufacturing development. As of September 30, 2021, Ocugen reported cash reserves of $107.5 million and a net loss per share of $0.05, highlighting significant growth in research and development expenses.
Ocugen, Inc. (NASDAQ: OCGN) announced the submission of an Investigational New Drug (IND) application to the FDA for OCU400, a gene therapy targeting retinitis pigmentosa caused by NR2E3 and RHO mutations. This Phase 1/2 clinical trial aims to evaluate the safety and proof-of-concept of the therapy in 18 patients. OCU400’s innovative platform could treat multiple retinal diseases with one product, having received orphan drug designations from the FDA for various conditions. The company aims to initiate a Phase 3 study post-trial, pending data analysis.
Ocugen has submitted a request for Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine candidate, COVAXIN™ (BBV152), for pediatric use (ages 2-18). This follows the World Health Organization's recent Emergency Use Listing for the vaccine. The submission is based on a Phase 2/3 clinical trial showing comparable neutralizing antibody responses in children to a previous adult trial. No serious adverse events were recorded in the pediatric study, suggesting a strong safety profile. COVAXIN™ has been administered in over 100 million doses globally, demonstrating promising efficacy and safety.
Ocugen, Inc. (NASDAQ: OCGN) announced a conference call on November 9, 2021, at 8:30 a.m. ET to discuss its Q3 2021 financial results and provide a business update. An earnings announcement will precede this call. Investors can join via dial-in numbers or webcast available on Ocugen's website. The company focuses on gene therapies for blindness and developing a COVID-19 vaccine. They are co-developing Bharat Biotech’s COVAXIN™ vaccine for the U.S. and Canadian markets.
Ocugen has submitted an Investigational New Drug (IND) application to the FDA to evaluate its COVID-19 vaccine candidate, COVAXIN™, based on the efficacy trial in India. This Phase 3 study is designed to assess the immune response in U.S. participants against the data collected in India. With over 25,000 participants in the Indian trial, COVAXIN™ showed 93.4% efficacy against severe COVID-19 and 77.8% against symptomatic disease. The study aims to enroll several hundred U.S. adults and to compare immunogenicity and safety data, targeting completion in H1 2022.
Ocugen, Inc. (OCGN) announced that its R&D head, Arun Upadhyay, PhD, will present pre-clinical data on OCU410, a modifier gene therapy candidate for Dry Age-related Macular Degeneration (Dry AMD), at the 2nd Annual Dry AMD Therapeutic Development conference on October 20, 2021. OCU410 targets the RORA receptor, which plays a crucial role in several physiological functions affecting Dry AMD, a condition impacting approximately 196 million people worldwide. The therapy is expected to enter clinical trials in 2022, following a collaboration with CanSinoBIO for its development.
Ocugen (NASDAQ: OCGN) announced the approval of stock options for 48,800 shares and restricted stock units (RSUs) covering 8,200 shares to three new employees as of October 16, 2021. The stock options, with a ten-year term, have an exercise price of $8.66 per share, equal to the closing stock price on the grant date. The options and RSUs will vest annually over three years, contingent on continued employment. This grant is made under Nasdaq Listing Rule 5635(c)(4) as a material inducement to employment.
Ocugen, a biopharmaceutical company (NASDAQ: OCGN), announced that CEO Dr. Shankar Musunuri will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 8 a.m. ET. He will discuss the company’s investigational COVID-19 vaccine COVAXIN™, co-developed with Bharat Biotech, and its innovative modifier gene therapy platform aimed at treating retinal diseases. The presentation will be accessible live and later on Ocugen's Investor Relations page.